Several publications and patent documents are cited throughout the specification in order to describe the state of the art to which this invention pertains. Each of these citations is incorporated herein by reference as though set forth in full.
Adhesions can occur following virtually all types of surgeries. Post-surgery trauma leads to inflammation which is a normal part of the healing process, but inflammation also encourages fibrous bands of scar tissue to develop, which can lead to adhesions. In addition to pain and bodily complications, adhesions lead to increased medical expenses. Costs include subsequent surgeries to remove or separate adhesions, doctor visits, pain medication and compensation for lost work time. Also, if a patient were to have a subsequent operation in the same surgical site, such operation can be complicated by existing adhesions. Surgeons have to spend a considerable amount of time removing the adhesions before a new procedure can begin. This may also prolong the patient's recovery time and increases the risk and cost of the surgery.
One of the procedures to reduce adhesion formation is to insert a physical barrier between potential adhesion forming tissue surfaces. INTERCEED® (Ethicon-brand absorbable adhesion barrier) and SEPRAFILM® (Genzyme-brand absorbable adhesion barrier) are the two FDA approved barrier devices available in United States. The success rates for INTERCEED® and SEPRAFILM® are 50% and 48% respectively. INTERCEED® is effective only in absence of blood contamination. SEPRAFILM® has low mechanical properties, is brittle and is difficult to handle. The success rates of these anti-adhesive barriers are still low and there is a need for development of more effective biomaterial, which can significantly reduce adhesions.